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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name urease and glutamic dehydrogenase, urea nitrogen
510(k) Number K872484
Device Name MODIFIED ENZYMATIC BUN REAGENT
Applicant
TRACE SCIENTIFIC LTD.
6135 NORTHWEST 167TH ST.
NO. E9
MIAMI LAKES,  FL  33015
Applicant Contact WILLIAM C RIDDLE
Correspondent
TRACE SCIENTIFIC LTD.
6135 NORTHWEST 167TH ST.
NO. E9
MIAMI LAKES,  FL  33015
Correspondent Contact WILLIAM C RIDDLE
Regulation Number862.1770
Classification Product Code
CDQ  
Date Received06/24/1987
Decision Date 08/19/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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